Bioequivalence Recommendations for Difluprednate; Revised Draft Guidance for Industry; Availability, 10775-10776 [2017-02972]
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10775
Federal Register / Vol. 82, No. 30 / Wednesday, February 15, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title:
Form OCSE–396, ‘‘Child Support
Enforcement Program Quarterly
Financial Report’’
Form OCSE–34, ‘‘Child Support
Enforcement Program Quarterly
Collection Report’’
OMB No.: 0970–0181.
Description: Form OCSE–396 and
Form OCSE–34 are financial reports
submitted following the end of each
fiscal quarter by grantees administering
the Child Support Enforcement Program
in accordance with plans approved
under title IV–D of the Social Security
Act. Submission of these forms enables
grantees to meet their statutory and
regulatory requirement to report
program expenditures and child support
collections, respectively, from the
previous fiscal quarter.
States use Form OCSE–396 to report
quarterly expenditures made in the
previous quarter and to estimate
program expenditures to be made and
the incentive payments to be earned in
the upcoming quarter. The
Administration for Children and
Families provides Federal funding to
States for the Child Support
Enforcement Program at the rate of 66
percent for all allowable and legitimate
administrative costs of this program.
Tribes use OMB Form SF–425 to
report quarterly expenditures made in
the previous quarter. Form SF–425 is
not included as part of this comment
request.
States and Tribes use Form OCSE–34
to report child support collection
activity during the previous quarter,
including collections received, the
distribution and disbursement of
collections and any collections
remaining undistributed.
The information collected in these
reports is used by this agency to
calculate quarterly Federal grant awards
and incentive payments to States, to
enable oversight of the financial
management of the program for both
States and Tribes and may be included
in statistical and financial reports
available to the public.
Respondents: 54 States (including
Puerto Rico, Guam, the Virgin Islands
and the District of Columbia) for Forms
OCSE–396 and OCSE–34 plus
approximately 60 Tribes for Form
OCSE–34.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
mstockstill on DSK3G9T082PROD with NOTICES
OCSE–396 .......................................................................................................
OCSE–34 .........................................................................................................
Estimated Total Annual Burden
Hours: 4,968.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
VerDate Sep<11>2014
18:44 Feb 14, 2017
Jkt 241001
54
114
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017–02979 Filed 2–14–17; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Bioequivalence Recommendations for
Difluprednate; Revised Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
revised draft guidance for industry on
generic difluprednate emulsion, entitled
‘‘Draft Guidance on Difluprednate.’’ The
recommendations provide specific
guidance on the design of
bioequivalence (BE) studies to support
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden hours
per response
4
4
4
9
Total burden
hours
864
4,104
abbreviated new drug applications
(ANDAs) for difluprednate emulsion.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 17, 2017.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
E:\FR\FM\15FEN1.SGM
15FEN1
10776
Federal Register / Vol. 82, No. 30 / Wednesday, February 15, 2017 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2007–D–0369 for ‘‘Draft Guidance on
Difluprednate.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ will be publicly viewable
at https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
VerDate Sep<11>2014
18:44 Feb 14, 2017
Jkt 241001
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730,
Silver Spring, MD 20993–0002, 301–
796–5850.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific BE guidances available to the
public on FDA’s Web site at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm.
As described in that guidance, FDA
adopted this process to develop and
disseminate product-specific BE
guidances and to provide a meaningful
opportunity for the public to consider
and comment on the guidance. This
notice announces the availability of
revised draft BE recommendations for
generic difluprednate emulsion.
FDA initially approved new drug
application 022212 for DUREZOL
(difluprednate emulsion) in June 2008.
In January 2016, FDA issued a draft
guidance for industry on BE
recommendations for generic
difluprednate emulsion. We are now
issuing a revised draft guidance for
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
industry on BE recommendations for
difluprednate emulsion (‘‘Draft
Guidance on Difluprednate’’).
In September 2016, Alcon
Pharmaceuticals, Ltd. and its affiliated
company, Novartis Pharmaceuticals
Corporation, submitted a citizen
petition requesting that FDA take
several actions with respect to ANDAs
for difluprednate emulsion, including
regarding the demonstration of BE for
any ANDA referencing DUREZOL. FDA
has reviewed the issues raised in this
citizen petition and is responding to the
citizen petition separately in the docket
for that citizen petition (Docket No.
FDA–2016–P–2781, available at https://
www.regulations.gov).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the design of BE studies to support
ANDAs for difluprednate emulsion. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: February 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–02972 Filed 2–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
SUMMARY:
E:\FR\FM\15FEN1.SGM
15FEN1
Agencies
[Federal Register Volume 82, Number 30 (Wednesday, February 15, 2017)]
[Notices]
[Pages 10775-10776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02972]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Bioequivalence Recommendations for Difluprednate; Revised Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a revised draft guidance for industry on
generic difluprednate emulsion, entitled ``Draft Guidance on
Difluprednate.'' The recommendations provide specific guidance on the
design of bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for difluprednate emulsion.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 17, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that
[[Page 10776]]
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Draft Guidance on Difluprednate.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' will be publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific BE
guidances available to the public on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
As described in that guidance, FDA adopted this process to develop
and disseminate product-specific BE guidances and to provide a
meaningful opportunity for the public to consider and comment on the
guidance. This notice announces the availability of revised draft BE
recommendations for generic difluprednate emulsion.
FDA initially approved new drug application 022212 for DUREZOL
(difluprednate emulsion) in June 2008. In January 2016, FDA issued a
draft guidance for industry on BE recommendations for generic
difluprednate emulsion. We are now issuing a revised draft guidance for
industry on BE recommendations for difluprednate emulsion (``Draft
Guidance on Difluprednate'').
In September 2016, Alcon Pharmaceuticals, Ltd. and its affiliated
company, Novartis Pharmaceuticals Corporation, submitted a citizen
petition requesting that FDA take several actions with respect to ANDAs
for difluprednate emulsion, including regarding the demonstration of BE
for any ANDA referencing DUREZOL. FDA has reviewed the issues raised in
this citizen petition and is responding to the citizen petition
separately in the docket for that citizen petition (Docket No. FDA-
2016-P-2781, available at https://www.regulations.gov).
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the design of
BE studies to support ANDAs for difluprednate emulsion. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
II. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: February 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-02972 Filed 2-14-17; 8:45 am]
BILLING CODE 4164-01-P